Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

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Detailed Description

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Conditions

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Hypotrichosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LATISSE®

bimatoprost ophthalmic 0.03% solution

Group Type EXPERIMENTAL

bimatoprost ophthalmic 0.03% solution

Intervention Type DRUG

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Placebo

vehicle sterile solution

Group Type PLACEBO_COMPARATOR

vehicle sterile solution (placebo)

Intervention Type DRUG

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Interventions

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bimatoprost ophthalmic 0.03% solution

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Intervention Type DRUG

vehicle sterile solution (placebo)

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Intervention Type DRUG

Other Intervention Names

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LATISSE®

Eligibility Criteria

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Inclusion Criteria

* African American/ethnic black
* Adults at least 18 years of age
* Eyelash prominence assessment of minimal or moderate

Exclusion Criteria

* Subjects with uneven lashes or longer on one side than the other
* Any eye disease or abnormality
* Eye surgery
* Severe hyperpigmentation around the eye
* Eyelash implants
* Eyelash extension application
* Any use of eyelash growth products within 6 months
* Any use of prescription eyelash growth products
* Treatments that may affect hair growth
* Requiring eye drop medications for glaucoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No